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dennis100
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« on: January 28, 2017, 03:06:09 AM »

Model Number 250
Event Date 06/28/2010
Event Type Malfunction
Event Description
A vns programming physician reported that his handheld was stuck on the align screen tutorial. A soft and hard reset had been performed neither of which worked. An analysis was performed on the returned handheld and the reported allegation was verified. During the analysis, it was identified that the touch screen display was no longer responsive. The cause for the display anomaly is associated with an intermittent trace that is connected to pin 4 of the touch screen display. Once the flex cable was pressed on the touch screen display, no further anomalies were identified during the analysis.

Manufacturer Narrative
Device malfunction occurred, but did not cause or contributed to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774379
« Last Edit: January 30, 2017, 01:46:37 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 28, 2017, 03:07:09 AM »

Model Number 250
Event Date 07/26/2010
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a site's (b)(6) handheld was not functioning properly. The site stated the screen was frozen and performing a soft reset and turning the device off and on did not resolve the issue. After performing a hard reset, the screen was no longer frozen, however, it would not let the site go past the align screen tutorial. A replacement handheld was sent to the site and the (b)(6) was returned to the manufacture for product analysis. During the analysis, it was identified that the touch-screen display was defective. The cause for the display anomaly is associated with a resistance value being higher than expected in the touch screen circuitry. Since the touch-screen display uses resistance values to determine the coordinates of a screen tap, the additional resistance associated with pin 4 caused the display to interpret the screen taps incorrectly. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824933
« Last Edit: January 30, 2017, 01:47:03 AM by dennis100 » Logged
dennis100
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« Reply #2 on: January 28, 2017, 03:08:00 AM »

Model Number MODEL 250
Event Date 02/08/2011
Event Type Malfunction
Event Description
It was initially reported that the physician's handheld screen was not responding to touch. A hard reset was performed multiple times but did not resolve the issue. There was no visible damage to the handheld. Good faith attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2037341
« Last Edit: January 30, 2017, 01:47:22 AM by dennis100 » Logged
dennis100
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« Reply #3 on: January 28, 2017, 03:09:00 AM »

Model Number 250
Event Date 03/01/2011
Event Type Malfunction
Event Description
It was initially reported that the physician's handheld screen was unresponsive. A hard reset was performed but the screen remained unresponsive and stuck on the "welcome to windows - touch the screen to continue". The handheld and flashcard were returned to the mfr for evaluation. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. During the analysis of the returned handheld, it was identified that the touchscreen display was defective. The cause for the display anomaly is associated with a resistance value being higher than expected in the touch screen circuitry. Since the touchscreen display uses resistance values to determine the coordinates of a screen tap, the additional resistance associated with pin 3 caused the display interpret the screen taps incorrectly. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061816
« Last Edit: January 30, 2017, 01:47:40 AM by dennis100 » Logged
dennis100
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« Reply #4 on: January 29, 2017, 02:47:35 AM »

Model Number 250
Event Date 08/27/2009
Event Type Malfunction
Event Description
Reporter indicated to the manufacturer that the handheld's screen would not respond to the stylus' tap. The anomaly was observed on several screens. Resets or troubleshooting did not resolve the event. The non-working device has been returned to the manufacturer for product analysis. Product analysis is currently pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1505061
« Last Edit: January 30, 2017, 01:48:01 AM by dennis100 » Logged
dennis100
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« Reply #5 on: January 29, 2017, 02:48:23 AM »

Model Number 250
Event Date 04/06/2011
Event Type Malfunction
Event Description
Our consultant in (b)(4) was contacted by a vns treating physician reporting that their handheld computer was not working. It was reported that the handheld was freezing and he could not complete the programming of patients. Our consultant went to the site and completed the software upgrade from version 7. 1 to version 8. 0 unfortunately, this did not resolve the problem. The consultant tried to program a patient using the same programmer but had the same issues. It was reported that the main problem is that when they tried to click on any icon, the handheld does not register, and therefore, does not move onto the next screen. Reported if you push the icon quite hard, it does register, however, continually doing this could cause damage to the screen. This only works on the first two screens and there comes a point where no matter what you do, the handheld does not register that an icon is being pressed. The 9v battery in the wand was changed and ruled out. Manufacturer is pending receipt of the handheld for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092434
« Last Edit: January 30, 2017, 01:48:22 AM by dennis100 » Logged
dennis100
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« Reply #6 on: January 29, 2017, 02:49:11 AM »

Model Number 250
Event Date 10/19/2009
Event Type Malfunction
Event Description
It was initially reported that the site was having to "tap her screen multiple times before it would move to the next screen. " the device was returned to the manufacturer for analysis, but has yet to be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553409
« Last Edit: January 30, 2017, 01:48:43 AM by dennis100 » Logged
dennis100
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« Reply #7 on: January 29, 2017, 02:49:54 AM »

Model Number 250
Device Problem Device inoperable
Event Date 10/12/2009
Event Type Malfunction
Event Description
Reporter indicated, a manufacturer representative's vns therapy programming handheld would not respond to tapping the touch screen. The handheld stopped responding to user input after the interrogation was started. The handheld was returned to the manufacturer. An analysis was performed on the handheld revealed no performance anomalies. An analysis was performed on the returned flashcard and the alleged screen freeze complaint is a known issue that has been evaluated and addressed through (b) (4) (event is readily confirmed). No other issues were observed with either the flashcard or software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1549701
« Last Edit: January 30, 2017, 01:49:03 AM by dennis100 » Logged
dennis100
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« Reply #8 on: January 30, 2017, 01:50:35 AM »

Model Number MODEL 250
Event Date 12/11/2008
Event Type Malfunction
Event Description
It was reported that a physician's handheld device was freezing during interrogating and would not respond to screen taps or resets. The physician requested that the handheld be replaced. A replacement handheld was sent out to the physician and good faith attempts to obtain, the old handheld device have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1360964
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dennis100
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« Reply #9 on: January 30, 2017, 01:51:33 AM »

Model Number MODEL 250
Device Problem Failure to align
Event Date 06/24/2009
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
The reporter indicated that he could not align the screen of his (b) (4) with his stylus, despite the amount of pressure that was used, and that the device would not progress from this screen. Troubleshooting steps were performed and were unsuccessful. The device was returned to software mfr and an analysis of the device revealed that the issue was associated with a defective screen. Once this screen was replaced with a known functional screen, device functionality was restored.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1480177
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dennis100
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« Reply #10 on: January 30, 2017, 01:52:22 AM »

Model Number MODEL 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's handheld device was not responding when the stylus pen was used. The physician was able to operate the handheld device using the buttons at the bottom of the device. The physician performed "a rest" of the handheld and the device would respond to stylus pen on the interrogation and programming menus; however, the handheld would no longer go back to the main menu screen. The physician was sent a replacement handheld and attempts to have the old handheld device returned to the manufacturer for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1346976
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dennis100
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« Reply #11 on: January 30, 2017, 01:53:08 AM »

Model Number 250
Event Type Malfunction
Event Description
A (b) (4) handheld computer was returned to manufacturer related to a reported screen freezing issue. When the screen was touched "nothing happened. " a soft reset and hard reset were performed that did not resolve the reported event. The handheld contained (b) (4) programming software and is pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1460085
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dennis100
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« Reply #12 on: January 30, 2017, 01:53:57 AM »

Model Number 250
Event Date 11/01/2008
Event Type Malfunction
Event Description
It was reported that the site was having problems with their handheld device. They could not get pass an error screen. On pressing harder, the screen cracked. Troubleshooting steps were performed, but it did not resolve the issue. New handheld was shipped to the site. Good faith attempts to have the old handheld shipped back to manufacturer have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354558
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dennis100
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« Reply #13 on: January 31, 2017, 01:22:03 AM »

Model Number MODEL 250
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Physician reported his handheld was freezing. It was successfully interrogate once the handheld was reset, however, when they tried hitting the menu button to run diagnostics, you had to hit the button 4-5 times before the menu screen would appear. Physician did not think the problem was with the alignment of the screen because he made sure it was correct. The handheld would not respond when you tap the screen. A replacement handheld was sent to the site. Product analysis is pending on the handheld.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1119850
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dennis100
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« Reply #14 on: January 31, 2017, 01:22:51 AM »

Model Number 250
Event Date 07/31/2008
Event Type Malfunction
Event Description
Reporter indicated that tapping on the "menu" button did not pull up the right selection. It was found that alignment for the upper right hand corner of the screen was off. By tapping on the upper part of the "menu" button, it successfully pulled down the right menu. Good faith attempts to obtain the product for analysis have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1148779
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dennis100
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« Reply #15 on: February 01, 2017, 02:48:01 AM »

Model Number 250
Event Date 01/01/2008
Event Type Malfunction
Event Description
Physician reported that when switching on the handheld, an exclamation point appears on the screen near the sign of the loudspeaker. After touching the exclamation point, the sign disappears. When performing interrogation, it takes several minutes before progressing to the next step. Physician thought that the screen froze, but after a few moments he received the interrogation results. Handheld and software are pending product analysis.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1079559
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dennis100
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« Reply #16 on: February 01, 2017, 02:49:02 AM »

Model Number 250
Event Date 05/22/2008
Event Type Malfunction
Event Description
It was reported that a dell handheld computer's screen kept freezing on different screens. It would "flicker" and "freeze" at different screens including when viewing device history/parameter history. It was also noted that the screen would freeze when the physician would try to change the parameters. The physician indicated resetting the device will resolve the screen freeze, but it happens quite frequently. A replacement handheld was sent to the site. Good faith attempts to obtain the product for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1063658
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dennis100
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« Reply #17 on: February 02, 2017, 03:18:42 AM »

Model Number MODEL 250
Event Date 04/01/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their hp computer had been left unplugged from the wall for some time. It was reported they were having trouble setting up the menu. Reported the hp had been charging for several days and when she tried to go thought the set up, the screen froze after the "yes to all" button was pushed. She said "she could not get past that screen. " she tried a hard reset and then got to the screen where you use the stylus to align the screen and "it froze again. " she tried this several times and could not get through the complete set up. The handheld and software were returned for analysis and the analysis was not able to duplicate the event. Software malfunction is the suspected cause of the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045083
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« Reply #18 on: February 03, 2017, 02:37:20 AM »

Model Number 250
Event Date 11/01/2007
Event Type Malfunction
Event Description
Reporter indicated, that his vns therapy programming handheld "was not responding, when he would tap it with the stylus. " troubleshooting did not resolve the issue. Good faith attempts are currently being made to obtain the handheld for product analysis.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968180
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« Reply #19 on: February 03, 2017, 02:38:04 AM »

Model Number 250
Event Date 09/24/2007
Event Type Malfunction
Event Description
Reporter indicated that the site's hp handheld computer screen had become frozen. Follow up with the site revealed that the nurse had not been able to move from the interrogation screen to the main menu. The nurse reported that when the stylus was used to tap on the menu button, the menu would not appear on the screen. The nurse reported that this happened a couple of times during one day, and it was reported that the handheld computer and software are functioning properly again.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=930369
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dennis100
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« Reply #20 on: February 03, 2017, 02:38:52 AM »

Model Number MODEL 250
Event Date 08/24/2007
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that the touch screen on the x5 handheld computer would not respond to the stylus. The handheld computer has been requested, but has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=914948
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dennis100
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« Reply #21 on: February 05, 2017, 01:56:27 AM »

Model Number MODEL 250
Event Date 06/22/2007
Event Type Malfunction
Event Description
Reporter indicated that her vns therapy programming handheld was malfunctioning. She stated that after resetting her handheld computer, it would not let her select any of the given options with the stylus. She was then instructed on how to do a hard reset. The hard reset was successful, but again none of the options could be selected with the stylus. She additionally reported " it was as if the screen was not recognizing the stylus tap. " the handheld and accompanying software were returned to mfr for product analysis, but the analysis is not yet complete.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=881453
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« Reply #22 on: February 13, 2017, 04:20:14 AM »

Model Number MODEL 250
Event Date 02/20/2013
Event Type Malfunction
Event Description
All attempts to the reporter for additional information and return of the computer have been unsuccessful to date.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Type of device, corrected data: previously submitted mdr indicated that the programming software was the suspect medical device, but this was actually the programming computer. This report is being submitted to correct this information. Device manufacture date, corrected data: previously submitted mdr indicated that the programming software was the suspect medical device, but this was actually the programming computer. This report is being submitted to correct this information.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns (b)(4) computer with version 8. 0 software had a frozen screen. A hard reset cleared the screen, but then the screen would no advance past the "align screen" prompt despite numerous attempts at aligning the crosshairs. Another hard reset was performed with the same result. Attempts for return of the computer for analysis and additional information are in progress.

Event Description
The handheld and flashcard were returned to the manufacturer. The handheld device was powered using the returned power supply with no anomalies. An attempt was made to perform the initial setup process, but could not be done. Several attempts to complete the align screen process were unsuccessful. The crosshair on the display would move when touched, but the utility would not advance to the next screen. The returned display was removed. Continuity testing of the returned display identified an anomaly associated with the trace that is routed to pin 1 of the touch screen flex cable. Resistance readings associated with the circuit were higher than expected (read 1. 2m ohm for pin 1 - nominal is approximately. 418k ohms). The flex cable was pressed where it attaches to the touch screen and it was identified that the resistance reading changed to. 482k ohms. The returned display was installed in the handheld in order to continue testing. The handheld device was powered using the returned ac power supply and the initial setup process performed with no anomalies. The handheld was powered-on continuously using only the main battery for more than an hour. The handheld computer was powered-on continuously using only the main battery for more than an hour. For five successful times the following occurred: the generator was interrogated, then the output and magnet currents increased from 0ma to 0. 5ma, then interrogated to verify the new settings, then a generator diagnostic test was performed during which the generator values were changed back to output currents of 0ma, and then the battery was interrogated to verify new settings. The main battery had a remaining charge of 71% at the conclusion of testing. No software anomalies were identified during the analysis. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. No further anomalies associated with the handheld performance were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3015880
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« Reply #23 on: February 13, 2017, 04:21:09 AM »

Model Number MODEL 250
Event Date 03/05/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
Additional information was received that product analysis was completed on the handheld and flashcard. During the analysis it was identified that part of the touchscreen was unresponsive. The cause for the anomaly is associated with a defective display. Once the display was replaced, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the physician handheld was not working correctly. The screen was not responding to stylus taps. Hard resets were attempted but did not resolve the issue. The screen was cleaned to rule out dirt/debris as the cause of the issue. The handheld and flashcard were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511074
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« Reply #24 on: February 27, 2017, 02:03:07 AM »

Model Number 250
Event Date 12/29/2009
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns (b) (4) handheld computer was not responding to taps from the stylus on the screen. The computer and flashcard have been requested for return but have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1593511
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« Reply #25 on: February 28, 2017, 08:46:47 AM »

Model Number MODEL 250
Event Date 06/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's handheld device was not functioning properly. The handheld device would not respond to the tap of the stylus on the screen. This event did not resolve following soft or hand reset of the programming device. The handheld is able to let the user progress past the alignment screen intermittently. A replacement device was sent to the physician upon request. The non-working device has been returned to the mfr where product analysis is currently pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1587969
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« Reply #26 on: March 04, 2017, 01:14:34 AM »

Model Number MODEL 250
Event Date 12/16/2013
Event Type Malfunction
Event Description
It was reported that the physician's handheld was unresponsive to the stylus. Troubleshooting was performed. The lock button was not engaged, hard resets were performed and the screen was cleaned. It was reported that the handheld still will not go passed the welcome screen. A new programming tablet was requested and the handheld, flashcard, and programming wand were returned for analysis. Analysis of the programming wand was completed on (b)(4) 2014. Internal visual inspection of the printed circuit board assembly and associated components revealed no anomaly. Continuity testing of the serial data cable and the battery cable passed. The programming wand performed according to functional specifications. Analysis of the handheld and flashcard are underway, but have not been completed to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3567773
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« Reply #27 on: March 04, 2017, 09:55:26 AM »

Model Number MODEL 250
Event Date 01/05/2015
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Manufacturer Narrative

Event Description
It was reported that the handheld screen was unresponsive. A couple of pixels in the middle of the screen were reportedly "gone" and not functioning. No physical damage was reported to have occurred. The screen was fully cleaned, the software card re-seated in the slot, and the device hard reset was performed; however, the problem persisted. A replacement device was requested. The suspect device was received by the manufacturer and is currently undergoing analysis.

Event Description
An analysis was performed on the returned handheld and the reported allegation of unresponsive screen was verified. The cause for the reported complaint is associated with damage to the top touchscreen layer. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software were identified during the flashcard analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4468486
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« Reply #28 on: March 04, 2017, 09:56:24 AM »

Model Number MODEL 250
Event Date 12/04/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, it was reported that this physician¿s handheld device would not responding screen touches around the ¿interrogate device¿ screen. A hard reset was performed, and the device proceeded pas the screen alignment with no error. All the other main menu options worked (i. E. User preferences and view database) as intended. The handheld device and software flashcard were returned and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3546419
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« Reply #29 on: March 04, 2017, 09:57:33 AM »

Model Number MODEL 250
Event Date 12/03/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Manufacturer Narrative

Event Description
It was reported that the nurse practitioner's handheld will not hold a charge. A new programming tablet was provided to the nurse practitioner. The handheld was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the returned handheld device and software flashcard was completed. No anomalies associated with the handheld main battery were identified during the analysis. The following anomalies were identified: 1) the battery latch was unlocked, preventing the handheld from turning on; 2) the display image was distorted and the inner display glass was cracked ¿ cause associated with mechanical stress; 3) the touchscreen was unresponsive ¿ cause associated with high impedance in the touchscreen circuitry, 4) the serial cable had an intermittent open connection causing the handheld to lose power intermittently while on ac power ¿ cause associated with mechanical stress. Following replacement with a known good screen, full product functionality was restored. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4393758
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